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Prognosis in postanoxic encephalopathy.


- candidate number7843
- NTR NumberNTR2244
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-mrt-2010
- Secondary IDsP10-017 METC Medisch Spectrum Twente
- Public TitlePrognosis in postanoxic encephalopathy.
- Scientific TitlePostanoxic encephalopathy: The prognostic value of EEG, TMS and SSEP.
- ACRONYMPrognosis in postanoxic encephalopathy
- hypothesisWe hypothesize that the neurologic prognosis of patients with post-anoxic encephaloptahy (due to a cardiac arrest) could be improved by combining SSEP measurements with continuous EEG monitoring and transcranial magnetic stimulation (TMS) measurements. With the addition of quantitative EEG features that can be extracted from the raw EEG and the use of continuous EEG recordings, providing trend curves, we hypothesize that prognostication can be significantly improved.
- Healt Condition(s) or Problem(s) studiedElectroencephalography (EEG), Transcranial magnetic stimulation (TMS), Somatosensory evoked potential (SSEP), Postanoxic encefalopathy
- Inclusion criteria1. Cardiac arrest;
2. Admitted to the ICU for therapeutic hypothermia;
3. Monitored with continuous EEG during the first 5 days of their hospital admission, or until the patient was extubated or discharged from the ICU;
4. Age above 18 years;
5. Obtained informed consent.
- Exclusion criteria1. Terminal illness;
2. Psychoactive or anticonvulsive medication;
3. Known history of a neurologic disease (stroke, parkinson, epilepsy);
4. Known history of brain surgery or severe brain trauma;
5. Known history of drug or alcohol abuse;
6. Severe neuropathy in the arms;
7. Not having two arms.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 15-apr-2010
- planned closingdate31-okt-2011
- Target number of participants20
- InterventionsNone.
- Primary outcomeThe main study endpoints will be the neurological outcome of the patient measured on the Glasgow-Pittsburgh Cerebral Performance Category (CPC) and EEG, TMS and SSEP measurements after one and three months. The endpoint will be compared with the quantitative EEG features that can be extracted from the raw EEG data and the TMS and SSEP responses measured at the ICU in the first days after the cardiac arrest.
- Secondary outcomeThe CPC determined six months after cardiac arrest by telephone.
- Timepoints1. EEG, TMS and SSEP Measurements during the first 5 days of hopital admission;
2. Follow up EEG, TMS and SSEP measurements after 1 and 3 months;
3. CPC score after 6 months.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMSc M.C. Cloostermans
- CONTACT for SCIENTIFIC QUERIESMSc M.C. Cloostermans
- Sponsor/Initiator Medisch Spectrum Twente
- Funding
(Source(s) of Monetary or Material Support)
University of Twente
- PublicationsN/A
- Brief summarySurvival rate after cardiac arrest is poor. Neurologic recovery is determined primarily by the extent of postanoxic encephalopathy (PAE). An early neurologic prognosis could be very helpful in these PAE patients. Absence of short latency somatosensory evoked potential (SSEP) has a good predictive value for poor prognosis in these patients. However, its sensitivity is only moderate. Also the electroencephalogram (EEG) has shown to correlate with the neurological outcome of PAE patients. Nevertheless, it is still impossible to give an early reliable prognosis for an individual PAE patient. We hypothesize that this prognosis could be improved by combining SSEP measurements with continuous EEG monitoring and transcranial magnetic stimulation (TMS) measurements. With the addition of quantitative EEG features that can be extracted from the raw EEG and the use of continuous EEG recordings, providing trend curves, we hypothesize that prognostication can be significantly improved. To test this hypothesis, we aim to do a follow-up study in PAE patients, which were previously admitted to our ICU for hypothermia treatment. These patients are monitored by continuous EEG and SSEP measurements during their first days of admission at the ICU. During this period we want to measure the response of a TMS pulse once a day as well. We will correlate these data with the Glasgow-Pittsburgh Cerebral Performance Category (CPC). To examine the recovery in patients with good neurological outcome in more detail, we want to do a follow-up study with additional EEG, TMS and SSEP measurements after one and three months in 20 PAE patients with good neurological outcome (CPC≤3).
- Main changes (audit trail)
- RECORD17-mrt-2010 - 7-jul-2010


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